Status:
COMPLETED
Phosphate Binder-combination Study of KHK7791 in Hyperphosphatemia Patients on Hemodialysis
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Hyperphosphatemia
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To evaluate the efficacy of KHK7791 in combination with phosphate binders by comparing changes in serum phosphorus levels between hemodialysis patients with hyperphosphatemia receiving repeated admini...
Eligibility Criteria
Inclusion
- Has voluntarily provided written informed consent to participate in the study.
- Aged ≥ 20 years (expressed in completed years) at the time of providing informed consent.
- Stable chronic renal failure patients who have undergone hemodialysis 3 times per week for at least 12 weeks until screening examination.
- Dialysis conditions, excluding dry weight, should have been unchanged during the last 2 weeks before screening examination.
- The prescribed drug and dosage regimen should have been unchanged during the last 4 weeks before screening examination.
- Serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 6.0 mg/dL at screening examination.
- If on any vitamin D, calcimimetics regimen, bisphosphonate,calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination.
- Kt/V urea ≥ 1.2 at the most recent test in routine medical practice before screening examination.
Exclusion
- Peritoneal dialysis was performed within 12 weeks before screening examination.
- iPTH \>600 pg/mL (should be based on the most recent value from the patients' medical records, etc. before pre-enrollment)
- Having concurrent or a history of inflammatory bowel disease (IBD) or diarrhea-predominant irritable bowel syndrome
- History of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination.
- Subjects who used anti RANKL preparations within 6 weeks before screening examination.
- Subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination.
- Having concurrent severe heart disease or hepatic impairment.
- Developed cerebrovascular disease requiring hospitalization within 6 months before screening examination.
- Uncontrollable hypertension or diabetes.
- Scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center (relocate to another hospital/clinic) during the study period.
- Any diagnosis of and treatment of malignancy within 5 years before screening examination (excluding basal cell carcinoma or surgically resected intraepithelial carcinoma of uterine cervix).
Key Trial Info
Start Date :
March 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2021
Estimated Enrollment :
169 Patients enrolled
Trial Details
Trial ID
NCT04766398
Start Date
March 15 2021
End Date
September 27 2021
Last Update
October 28 2021
Active Locations (1)
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1
Inoue Hospital
Suita, Osaka, Japan